Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
Abstract
ISO 22442-3:2007 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.
DIN EN ISO 22442-3:2008-03 (E)
Medical devi ces utilizing animal tissues and their derivatives – Part 3: Validation of
the elimination and/or inactivation of viruses and transmissible spongiform
encephalopathy (TSE) agents (ISO 22442-3:2007)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 General requirements ……………………………………………………………………………………………………..7
4.1 Risk management ……………………………………………………………………………………………………………7
4.2 Sourcing and manufacturing process ……………………………………………………………………………..7
4.3 General requirements related to validation ………………………………………………………………………7
5 Literature review ……………………………………………………………………………………………………………..8
5.1 Conduct of the literature review ………………………………………………………………………………………8
5.2 Application of literature review output …………………………………………………………………………….8
5.3 Viruses …………………………………………………………………………………………………………………………..8
5.4 TSE agents ……………………………………………………………………………………………………………………..8
6 Elimination and/or inactivation study of viruses and TSE agents ……………………………………..9
6.1 General …………………………………………………………………………………………………………………………..9
6.2 Protocol ………………………………………………………………………………………………………………………….9
6.3 Conduct of the study …………………………………………………………………………………………………….10
6.4 Interpretation of data …………………………………………………………………………………………………….10
7 Final report ……………………………………………………………………………………………………………………10
8 Review of final report …………………………………………………………………………………………………….10
9 Routine monitoring and control of critical process parameters ………………………………………10
Annex A (normative) Requirements related to literature review ……………………………………………………..11
Annex B (informative) Guidance on the elimination and/or inactivation study for viruses ………………15
Annex C (informative) Guidance on the elimination and/or inactivation study for TSE agents ………..20
Annex D (informative) Guidance on scaling down …………………………………………………………………………21
Annex E (informative) Statistical evaluation of virus titres and reduction factors and assessment of
their validity ………………………………………………………………………………………………………………….22
Annex F (informative) Calculation of reduction factors ………………………………………………………………….24
Annex G (informative) Probability of detection of agents at low concentrations …………………………….23
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC as amended by Commission Directive
2003/32/EC …………………………………………………………………………………………………………………… 25
Bibliography ……………………………………………………………………………………………………………………………….. 26